Recruiting

TPDAcute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

Sponsor:

ULURU Inc.

Code:

NCT05424354

Conditions

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Altrazeal (R) Transforming Powder Dressing

Standard of Care burn dressing

Study Details

Brief summary:

This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.

Conditions

Wounds and Injuries

Study ID

NCT05424354

Start date

May 26, 2022

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
Wounds must be partial thickness, involving up to 20% of the total body surface area.
Burn injury should be less than 72 hours old
Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
Willing and able to provide written informed consent.

Exclusion Criteria:

Known allergy to TPD or its components

Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
Infected wounds
Presence of any full thickness (third degree) burns
Electrical burns
Heavily draining burns due to underlying chronic lymphedema or other conditions
Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
History of poor wound healing and/or skin/immune system condition

Deemed by clinician not to be suitable
Unwilling or not able to provide consent or comply with protocol or required visits
Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
Active alcohol or substance abuse

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transforming Powder Dressing

Half of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

active comparator: Standard of Care Dressing

Half of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing).

Interventions

Altrazeal (R) Transforming Powder Dressing

After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.

Standard of Care burn dressing

Primary outcome measure

Pain from the Burn Wound [ Time Frame: 28 days (or sooner if the wound heals prior to 28 days) ]

Central Contacts and Locations

Central contacts

Vai Shah

2149055145 vshah@uluruinc.com

Susan St John, MSN

4123035379 sstjohn@uluru.com

Locations

University of California-Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Lizette Spears

714-456-5840 lspiers@hs.uci.edu

Taina Aruju

714-456-5840 taraujo@hs.uci.edu

Principal Investigator:

Victor Joe, MD

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Mary (Abby) Bellon

202 877 3519 Mary.A.Bellon@medstar.net

Principal Investigator:

Jeffrey Shupp, MD

Jackson Memorial Hospital UM/JMH Burn Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Lisa Otero, BA

305-585-1348 lao77@med.miami.edu

Principal Investigator:

Carl I Schulman, MD

University of Louisville Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Madison Rutledge

(502) 629-3327 madison.rutledge@louisville.edu

Michelle Broers

michelle.broers@uoflhealth.org

Principal Investigator:

Matthew Bozeman, MD

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Daniela Santamaria-Vargas, MSc

9144931528 Daniela.Santamaria-Vargas@wmchealth.org

Falyn Katzman, MPH

falyn.katzman@wmchealth.org

Principal Investigator:

Joseph Turkowski, MD

University of Texas SW (Parkland)

Recruiting

Dallas, Texas, United States, 75235

Contacts

Scarlett Dwyer

214 645-0445 Scarlett.Dwyer@utsouthwestern.edu

Principal Investigator:

Caroline Park, MD

More Information

Sponsor

ULURU Inc.

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

burn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ULURU Inc. on 2025-11-19.